• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE VENTED VIAL ACCESS DEVICE SET, IV FLUID TRANSFER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON BD SMARTSITE VENTED VIAL ACCESS DEVICE SET, IV FLUID TRANSFER Back to Search Results
Catalog Number MV0420-0006
Device Problems Complete Blockage (1094); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2021
Event Type  malfunction  
Event Description
It was reported bd smartsite vented vial access device had 1 report of damaged product, 1 report of leakage, 1 report of flow issues, and 1 report of occlusion. The following information was provided by the initial reporter: "row 1 - break at insertion point/vent junction row 2 - clog/do not perfuse as soon as they are placed in the vial (do not work) row 3 - the anchoring tabs that hold the ampoule neck break very easily row 4 - the piercing agent in rubber breaks easily".
 
Manufacturer Narrative
The manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Investigation summary: a product sample was not available for investigation; however the customer confirmed the complaint sample material number and lot number. From the information provided by the customer it appears that the customer experienced a damaged spike component during attempted vial access. The root cause of the customer¿s experience could not be determined as the sample was not available for investigation. In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience. A review of the production records for the provided lot number did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. Previous investigations have confirmed that damage to the spike can be caused by an angled insertion technique (sometimes referred to as an "anti coring vial access technique") of the spike into the vial causing the spike to be pushed into the side wall of the vial. In this instance as the sample was not returned for investigation it could not be determined if this may have contributed to the customer's experience. A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the product over the past 12 months.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD SMARTSITE VENTED VIAL ACCESS DEVICE
Type of DeviceSET, IV FLUID TRANSFER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12840274
MDR Text Key286080839
Report Number2243072-2021-02756
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMV0420-0006
Device Lot Number202040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-